MedTrace Logo

Effect of Amiodarone on the Procedure Outcome in Long-standing Persistent Atrial Fibrillation Undergoing Pulmonary Vein Antral Isolation

NCT01173809 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2014-08-21

No results posted yet for this study

Summary

This prospective randomized study aims to investigate the effect of continuous versus interrupted use of Amiodarone on the procedure outcome in long-standing persistent (LSP) atrial fibrillation patients undergoing pulmonary vein antral isolation (PVAI).

Conditions

Interventions

DRUG

Amiodarone

Patient will continue taking Amiodarone before, during and after ablation (8 weeks post-ablation).

DRUG

Amiodarone

Amiodarone therapy will be stopped at least 5-months before ablation procedure and ablation will be performed off Amiodarone. Patients will not take Amiodarone during the blanking period (8 weeks post-ablation).

Sponsors & Collaborators

  • University of Kansas

    collaborator OTHER

  • California Pacific Medical Center

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • Case Western Reserve University

    collaborator OTHER

  • Southlake Regional Health Centre

    collaborator OTHER

  • Catholic University, Italy

    collaborator OTHER

  • Texas Cardiac Arrhythmia Research Foundation

    lead OTHER

Principal Investigators

  • Andrea Natale, MD · TCAI, St.David's Medical Center

  • Luigi Di Biase, Md, PhD · Texas Cardiac Arrhythmia Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-05-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01173809 on ClinicalTrials.gov